Ética Em Pesquisas Com Seres Humanos: Do Conhecimento À Prática

Einstein (São Paulo), 2014

Council (CNS, acronym in Portuguese), (1) approves the regulatory guidelines and norms for research involving human beings and constitutes the first national regulatory mark of ethics applied to research. By means of this resolution, the Brazilian system of ethics review was created, composed by the Research Ethics Committees (CEPs, acronym in Portuguese) and the National Research Ethics Commission (CONEP, acronym in Portuguese), also known as the CEP/CONEP System. After 15 years, the process of review of CNS Resolution no. 196/96 was initiated. This involved public consultation during the period of September 12 to November 10, 2011, which resulted in 1,890 suggestions sent electronically and the presentation of 18 documents sent by mail. These contributions, duly tabulated, were submitted to the analysis of participants of the extraordinary National Meeting of Research Ethics Committees that produced a document and submitted it to the CNS.

Cadernos de saude publica, 2015

The bill submitted to the Brazilian Senate for ethical regulation of clinical research is contrary to the interests of research subjects A proposta de regulamentação ética da pesquisa clínica apresentada ao Senado Brasileiro não interessa aos participantes de pesquisa La propuesta de regulación ética de la investigación clínica presentada al Senado brasileño no interesa a los participantes de la investigación

BMC Medical Ethics, 2022

Background: Brazil is among the sixteen countries that conducts the most clinical trials in the world. It has a system to review research ethics with human beings made up by the National Commission on Research Ethics (CONEP) and 779 Research Ethics Committees (RECs), in 2017. The RECs are supposed to follow the same rules regarding their membership, although the RECs that review Social Science and Humanities (SSH) researches must respect Resolution 510/16. There are Brazilian RECs that review SSH and clinical trials. This study aimed to analyze the academic professional profile of the members of the CONEP and Brazilian RECs, their adequacy to the norms, and the challenges faced by the REC's Chairs to compose their membership. Methods: All 779 Brazilian RECs' chairs are invited to fill in a questionnaire informing academic and professional background of the RECs members, and 92 answered. However, eight were excluded for having sent an incomplete questionnaire, leaving a total of 84 participants. The variables were described by absolute and relative frequency. The Chi-square test and ANOVA was used to analyze regional differences related difficulties to compose the committee. The significance level was 95%. Results: The results showed a predominance of members from the biomedical area (57%), while 33% were members of the Social Sciences and Humanities and 5.5% were community representatives. As for the academic degree, there were (45.2%) PhD and (27.9%) masters. The divergences in relation to the guidelines result from the difficulties of having participants in some areas and the little interest in the work carried out by the committees. Conclusion: The RECs are partially adequate to the norms and their performance may be compromised by the low participation of community representatives. The organization of REC's specifics to review biomedical research could improve the ethical review process, ensuring a membership more qualified for these protocols.

Research Integrity and Peer Review, 2017

System is a scientific quarterly journal published by the Brazilian Ministry of Health. The journal publishes mainly original articles that report research involving human subjects, in accordance with its mission: to disseminate epidemiological knowledge applicable to surveillance, prevention and disease control relevant to Public Health. This report aims to describe the ethical considerations presented in the original articles published from 2014 (v. 23, n. 1) to 2016 (v. 25, n. 1). One hundred forty-seven original articles were published (10 issues), 8 were excluded because they did not report research involving human subjects. We checked for the description of the following items in the Methods section: Human Research Ethics Committee (HREC) approval, date of approval, registry number, and informed consent. We reviewed 139 original articles. HREC approval was mentioned in 45/45 articles that reported use of primary data, 16/16 that reported use of secondary data from surveys, 30/62 that reported use of secondary data from health information systems, 12/13 that reported use of medical records, and 3/3 that reported studies conducted with both primary and secondary data. All 48 articles that reported studies with primary data described the HREC registry number, 34 mentioned obtaining of informed consent, and 7 provided the date of HREC approval. Among the 91 articles that reported studies conducted exclusively with secondary data, 51 included HREC approval, 55 provided the registry number, and 29 the date of HREC approval. Thus, all articles that reported studies Peer Review

Arquivos de Medicina

OBJECTIVE: Diagnose ethical conduct in research involving human beings in Brazil and the last 10 years of activity by the Human Research Ethics Committee of the Health Department - Federal District - CEP/SES/DF. METHODS: This work was based on a documentary research, descriptive and retrospective. It examined the database containing records of cases brought before the CEP/SES/DF, corresponding the period of June 1997 to December 2007. Results were generated in Excel program, version 2007. RESULTS: CEP/SES/DF has presented increasing number of research projects submitted to appreciation (n = 1129), composing: 90.4% approved 1.7% disapproved, 7.4% removed/filed and 0.5% excluded. Of these projects, 83% belonged to Group III, 18% multi-centered projects and 10% protocols with foreign participation. Time for approval has decreased over the years (30 to 60 days). Frequent pendencies: End of Free and Informed Consent (30%), Cover Sheet (25%), Methodology (20%), Curriculum vitae (12%), Bud...

The bill submitted to the Brazilian Senate for ethical regulation of clinical research is contrary to the interests of research subjects A proposta de regulamentação ética da pesquisa clínica apresentada ao Senado Brasileiro não interessa aos participantes de pesquisa La propuesta de regulación ética de la investigación clínica presentada al Senado brasileño no interesa a los participantes de la investigación

Revista Bioética, 2017

This study aimed to characterize the Research Ethics Committees in their profile and operationalization. An electronic questionnaire was sent to the 645 existing committees at the time and answered by 129 coordinators. The answers were categorized by frequency and mean of the answers and passed by a statistical test. The results indicated that most of the coordinators had a degree in Biological and Health Sciences, at Masters and PhD levels. The committees had been operating for more than nine years in higher education institutions, with insufficient institutional support. Members were empowered by readings of the Committee's regulations and guidelines. The distribution of protocols was done by subject affinity and the group decision was given by consensus or vote. It is concluded that the committees are consolidated, comply with ethical regulations, but they need to dialogue more with researchers and with the National Commission of Ethics in Research.

Revista gaúcha de enfermagem, 2016

Dificultades y desafíos en revisión de aspectos éticos en investigación en Brasil

International Journal of Nutrology, 2022

Since October 1996, Brazil has a new regulation on research involving human beings, it is the Resolution nº 196 of 1996 of the National Health Council, instance in which the National Research Ethics Commission and the Ethics Committees were created in Research-EC. This resolution says that each and every research project, in any area, involving human beings must contain an analysis of ethical aspects-carried out by the researcher himself-and be approved by the Research Ethics Committee. Research involving human beings is understood to be that which, individually or collectively, directly or indirectly involves human beings, in their entirety or parts of them. This article reports the difficulties in developing a research project that will later be approved by an EC, but with an emphasis on why these difficulties exist.

Psicologia: Reflexão e Crítica, 2015

Brazilian associations for research in human, social and applied social sciences have long sought ethical aspects regulation compatible with the epistemological, theoretical and methodological specificities of these sciences. Consequently, the Brazilian regulatory system (Research Ethics Committees/CEPs of the National Research Ethics Commission/CONEP) is currently undergoing an important review process. This article presents the positions taken by the National Association of Research and Postgraduate Studies in Psychology-ANPEPP. The article: (1) highlights the origins of the current ethics review model, based on biomedical research; (2) summarizes criticisms recurrent to this model; (3) identifies the directions required for the improvement of the system; and (4) lists the challenges to be overcome in the current process of creating specific regulations for the human and social sciences. The considerations presented highlight two crucial points that challenge the construction of a specific resolution for research ethics in the human and social sciences: (1) the clear characterization of what is meant by 'research in the human and social sciences'-and that would, therefore, have its ethical review regulated from the perspective of the specific resolution for the human and social sciences; and (2) the definition of parameters from which different risk levels in studies can be identified.